Why I’m Holding My Moderate AVXL Position
Irrespective of the many postings telling why Anavex 2-73 is not likely to provide sufficiently favorable clinical results to allow or prompt FDA approval of the drug for commercial use, on the basis of the information below I’m holding my moderate AVXL position until complete regulatory resolution; until the drug gains approval for sale and use in any particular country.
In several years (I’m looking over the horizon, to 2023) my investment in Anavex Life Sciences Corp will have proven exceptionally rewarding; or the company will have gone bust and I will have lost my investment dollars. For the reasons below (and others), I think I will win.
1. I am a biologist, know and understand the functions and chemical reactions in neuron organelles; understand the ample body of evidence showing that Anavex 2-73 reconnects disconnected mitochondria with their associated endoplasmic reticula. This rejuvenates neuron functions. With this, the endoplasmic reticula can fold proteins into their proper shapes, allowing normal neuron chemistries to occur, obviating the many pathologies caused by mitochondrial dysfunctions (including most forms of Alzheimer’s, Parkinson’s, and a number of other central nervous system conditions).
2. There is an ample number of murine (rat and mice) studies showing significant therapeutic outcomes against various mitochondrial dysfunction diseases. Mice, neurologically are (to a degree) “men.” Conversely, I’ve discovered no murine studies showing that Anavex 2-73 fails to restore mitochondrial functions in transgenic murines (with transferred pathological disease genes, particularly Alzheimer’s).
3. Wonderfully, Anavex 2-73 is ably absorbed in the gut and crosses the blood/brain barrier, and, finally, diffuses into or is absorbed into the intracellular space of neurons. As in the murine studies, this means that in humans it can be administered orally, not by intravenous or intramuscular injection.
4. The small human Australian trail was conducted to assess only safety and tolerability; not any generalized Alzheimer’s treatment efficacy. Safety in humans was clearly established, with no severe or disqualifying side effects (merely a few head aches, etc.). Adverse events are a major concern and common, almost universal occurrence with psychoactive drugs. Anavex 2-73 had none of any significance. Tolerability, dosage effects, were determined, yielding no results to prevent anticipated dosages in consequent human trials. Safe and tolerable.
5. Although not designed as a test for desired efficacies, the Phase I Australian trial had a number of participants gain astounding reversals of their Alzheimer’s symptoms; approaching or attaining normal cognition. Yes, the trial cohort (number of participants) was too small to extrapolate these very positive outcomes to a larger, statistically-valid population. Nonetheless, attributing those disease turn-arounds to mere chance dismisses or discounts what is known to happen in virtually all Alzheimer’s cases. It is universally a lethally progressing disorder. Symptomatic turn-arounds such as those in the Australian trial are virtually unknown. They were plausible because they happen in transgenic murines with Alzheimer’s symptoms and genes, treated with Anavex 2-73.
6. Curiously, the majority of the Australians in the small safety and tolerability trial elected to, and were given permission to continue taking Anavex 2-73 after the formal, monitored study was completed. This has continued without interruption now for many months. Two supportive factors. Australian medical officials had to give their permission to allow the trial participants to continue to take the drug, even though the trial itself ended. The reasons Australian officials allowed this (never disclosed) can only support the notion that the drug is both safe and, at least to some degree, effective. Likewise, the patients, for whatever reasons, personally elected to continue to take the drug. That would not have been the case had they perceived it to cause problems, or be without some health benefit.
7. Anavex Life Sciences Corp has not just Anavex 2-73, but a number of other proprietary molecules with equivalent or exceptional neuron rejuvenation powers. Preclinical murine studies of Anavex 3-71 suggest that it is even more efficacious against a number of human conditions than Anavex 2-73. The Anavex drug pipeline is ample, with a number of promising molecules that may eventually treat or prevent a host of human diseases and conditions.
8. Not a single murine study has shown Anavex 2-73 to fail to provide some degree of symptomatic relief for appropriately targeted conditions. There is no body of evidence showing that the drug fails.
Investing in start-up biotechs with only a promising story, with no approved drugs or devices to sell is a risk. For Anavex Life Sciences Corp it’s a risk I’ve decided to take with my moderate holding of AVXL shares. To determine this success, I’ll will wait until at least 2023, allowing time for everything required to work out. For me, the existing evidence says that it will.
AI
